Download information form - Genzyme in India

Report of an Individual Safety Information (ISI)
1) Reporter
Name (First/Last)
Address
2) Patient
Phone / Email / Fax
Country
Initials Gender Select
3) Reaction
Occupation:
Date of Birth/Age at onset/
Age Category
Height (cm)
Diagnosis
Weight (kg)
Date of Onset
Reaction description, signs & symptoms, possible causes, progression, treatments, relevant medical history, investigations, disease registry
name
Please check if the reaction led to one of the followings:
Death
Life-Threatening
Inpatient/ Prolonged Hospitalization
Congenital Anomaly/ Birth Defect
Persistent or Significant Disability / Incapacity
Suspected transmission of infectious agent
Required Intervention to Prevent Permanent
Impairment or Damage (Devices)
4) Action Taken
None
Dose changed specify:
Discontinued
Did reaction reoccur after drug was restarted?
Corrective treatment was required,
5) Outcome of Reaction:
Recovered
Yes
No
Did reaction abate after drug was stopped or dose changed?
Unk
Yes
No
Unk
specify:
Date of Resolution, if not available, reaction duration:
Recovered with sequelae: specify:
Fatal, specify date & cause of death.
_ ___
Recovering
Not Recovered
__________________________________________________ Autopsy:
Yes
No
Unknown
Unk
6) Medication/Device potentially causing the reaction
Trade/Brand name & or INN (strength &
form)
Indication
Dosage/Unit/
Freq/
amount
Route
Treatment
start date
Treatment stop
date /duration
Lot/Batch
Company (C)
or noncompany
(NC)
Select
Select
7) Other Medication/ Device
Select
Select
Select
Select
Case submitted to any Regulatory
Authority
Signature / Date:
First received Date:
Name: ( First /Last)
Local PV received Date:
Name: ( First /Last)
Local PV Ref. No.
Local PTC No.
Global PTC No.
AWARE Case No.
Grey fields for Company use only. (Please send this completed page to [email protected]. Please contact +91- 98200 69843 for any assistance)
Unsolicited Individual Safety Information (ISI) Report Form and Instructions
QSD-001034 Version Number: 9.0
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General Instructions for Individual Safety Information Form
Completion

These instructions are designed to assist you in completing this Individual Safety Information
(ISI) form used by Sanofi to collect and document safety information on their products. Although
not all fields are detailed in the following instruction, all of the fields must be completed if
applicable.

Type or print using black ballpoint pen only.

Make changes or corrections by drawing a single line through the ERROR. Initial and date all
corrections. DO NOT use correction fluid.

Answer questions as concisely as possible. If the safety information does not fit into the
structured fields, you may use additional pages as necessary. Ensure each additional page
includes the page number and the total number of pages forwarded.

Enter dates in DD-MON-YYYY format (e.g. 20-Apr-2011). Partial dates are acceptable. For
example: Apr-2011 2011.

Do not fill out Grey fields on the ISI form. They are for Sanofi use only.
Unsolicited Individual Safety Information (ISI) Report Form and Instructions
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Section 1): Reporter
Field:
Instructions for completion:
Reporter Name
Enter the primary reporter’s First and Last Name or initials as appropriate.
This field should be anonymized before transmission to Core Teams.
Phone / Email / Fax
Enter the primary reporter’s Phone number, Email address, and/or Fax
number, as available and as appropriate.
Address
Enter the primary reporter’s address including street address, state,
country, as appropriate.
Country
Enter reporter’s country.
Occupation
Enter reporter’s occupation, e.g. consumer, physician, nurse, dentist,
pharmacist…
Section 2): Patient
Field:
Initials
Instructions for completion:
Enter patient’s Initials.

Use the first letter from the “first, middle, last (family)” names. If no
middle initial, or it is unknown, enter first letter of “first, last” names.
For example:
o RAB, RB, R-B

If the case includes a group of patients (e.g., literature article) and
there are no initials, the identifier would be “Patient 1”, “Patient 2, or
note a number of patients (e.g., patient 1 to patient 6).
Gender
Enter Patient’s gender – Male (M) or Female (F) or unknown (Unk)
Date of Birth / Age at
time of onset / Age
Category
Enter Patient’s date of birth.
If not available, enter the age at the time of onset of the primary reaction.
If none available, enter Patient’s Age Category.
Height / Weight
Age Group
Category
Definition (defined in completed days, months or
years)
Fetus
During gestation, prior to birth
Neonate
0 to <28 days
Infant
≥ 28 days to <24 months
Child
≥ 2 years to < 12
Adolescent
≥ 12 years to < 18 years
Adult
≥ 18 years to < 65 years
Elderly
≥ 65 years
years
Enter Patient’s height in cm / Enter Patient’s weight in kg
Unsolicited Individual Safety Information (ISI) Report Form and Instructions
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Section 3): Adverse Reaction
Field:
Diagnosis
Instructions for completion:
Enter the diagnosis as reported. Provide final reporter’s diagnosis rather
than signs and symptoms whenever possible.
If there is more than one (1) reaction, capture the most significant one in
this field, and the additional reactions in the reaction description of the ISI
form
Date of Onset
Enter the Date of Onset of the diagnosis.
Reaction Description
Provide a detailed chronological description of the reaction, including
alternative etiology (including relevant medical history or concomitant
diseases etc.), confounding factors, treatment of reaction, and outcome.
Include relevant tests/ investigation results (specify test type and results
with units), and applicable dates. Specify any abuse, lack of efficacy,
medication error, misuse, occupational exposure, off label use or
overdose.
Clearly delineate follow-up / additional information from initial information
when possible.
Provide list of available information and attach if relevant. E.g., hospital
notes, discharge summaries, etc.
Unsolicited Individual Safety Information (ISI) Report Form and Instructions
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Section 3): Adverse Reaction
Field:
Please check if the
reaction led to one of
the following
Instructions for completion:







Death should be indicated if the subject died at the time of, or at
some time after the onset of this reaction. Please note that death
is an outcome and not a reaction. Record the reaction that
resulted in death
Life Threatening is a reaction in which the subject was at
immediate risk of death at the time of the reaction as it occurred; it
does not refer to a reaction that hypothetically might have caused
death if it was more severe
Inpatient/Prolonged Hospitalization should be indicated if the
reaction resulted in the subject formally being admitted to hospital
as an in-patient or prolonged the stay of an existing
hospitalization. An Emergency Room visit does not qualify
Congenital Anomaly / Birth Defect should be indicated if the
reaction is a congenital abnormality/birth defect
Persistent or Significant Disability / Incapacity should be indicated
if the reaction resulted in a substantial disruption of a person’s
ability to conduct normal life and functions
Suspected transmission of infectious agent is any suspected
transmission of an infectious agent via a medicinal product (e.g.,
product contamination)
Required Intervention to Prevent Permanent Impairment or
Damage (Devices) should be indicated If you believe the
intervention was necessary to preclude permanent impairment of
a body function, or prevent permanent damage to a body
structure, either situation suspected to be due to the use of a
medical product
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Section 4): Action Taken
Field:
Action taken
Instructions for completion:
Check what action was taken concerning the suspect product(s).



None – no change in the regimen of the suspect drug.
Discontinued – drug was discontinued
Dose changed, specify the change. E.g., dose decreased,
increased, frequency decreased…
As applicable:


Check Yes/No/Unk if reaction reoccurred after the drug was
restarted.
Check Yes/No/Unk if reaction abated after the suspect drug was
stopped or dose was changed
Check the tick box if corrective treatment was given. Specify all
treatments given to treat the reported reaction.
Note: If more then one suspect product, with different actions taken,
detail in reaction description section.
Section 5): Outcome of Reaction
Field:
Instructions for completion:
Outcome of Reaction
Check the outcome of the Main reaction at the time of this report.
Check one:
 Recovered,
 Recovered with sequelae, (Specify sequelae),
 Recovering,
 Not (yet) recovered,
 Unknown,
 Fatal. (If the person died, specify the causes, circumstances and
date of death)
o Autopsy: Check Yes/No/Unk, if an autopsy was
performed, attach report if available
Date of Resolution or
Duration
Enter the Date of Resolution of the main reaction, if the reaction has
resolved at the time of report completion. Enter duration if date of
resolution is not available.
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Section 6): Medications / Devices potentially causing the reaction
Field
Instructions for completion:
Trade / Brand name &
or INN (strength & form)
Provide the local trade / brand name or International Nonproprietary Name
(INN) of the suspect medication or device if available.
Specify the strength and dosage form.
Indication
Provide the reason the drug / device was prescribed or taken by the
patient (approved or unapproved indication) If the indication is unknown,
indicate this.
Dosage/ Unit /
Frequency / Amount
Enter the dosage, dosage unit and frequency. If different dosages and
frequencies were used, use multiple lines or another page to enter the
appropriate information with the most recent dosage and frequency first.
If a Device, specify the amount used, or implanted if applicable.
Route
Enter the route of administration. If product was administered via an
incorrect route, specify the actual route of administration.
Treatment Dates
Enter the start date of treatment.
Enter the stop date of treatment, if applicable.
If no start date or stop date, enter approximate duration of treatment.
Lot/Batch No.
Provide the lot/ batch number and expiration date if available.
Company or NonCompany product
Note if company (C) or non-company (NC) product
Section 7): Other Medication or Device
Field
Other Medication /
Device
Instructions for completion:
Other medications are those taken or administered within at least two
weeks prior to the onset date of the primary clinical reaction.
Exclude drugs used to treat the reaction.
NOTE: See section 6) for instructions for similar fields.
Case Submitted to any
Regulatory Authority
Check if submitted to any Regulatory Authority.
Date / Signature
Reporter’s signature
Unsolicited Individual Safety Information (ISI) Report Form and Instructions
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